Company ยท US
Hycel, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1980. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 5 |
| CFH | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase | 2 |
| CCY | Zimmerman (Spectrophotometric), 17-Ketosteroids | 1 |
| CDB | Porter Silber Hydrazone, 17-Hydroxycorticosteroids | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| GKK | Cyanomethemoglobin | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 |
| JJO | Flame Emission Photometer For Clinical Use | 1 |
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | 1 |
| JPJ | Red-Cell Indices, Calculated | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 6, 1980 | K802422 | HYCEL TRIGYCERIDE II TEST Hycel, Inc. | |
| Feb 27, 1979 | K790335 | HYCEL M Hycel, Inc. | JJF |
| Jan 26, 1979 | K782176 | HYCEL LDH-INT TEST Hycel, Inc. | CFH |
| Jan 26, 1979 | K782116 | KETOSTEROID TEST, HYCEL-17 Hycel, Inc. | CCY |
| Jan 3, 1979 | K782102 | HYCEL COUNTER 211 Hycel, Inc. | GKL |
| Jan 3, 1979 | K782101 | HYCEL COUNTER 222 Hycel, Inc. | GKL |
| Jan 3, 1979 | K782100 | HYCEL COUNTER 333 Hycel, Inc. | GKL |
| Jul 27, 1978 | K781004 | HMA URIC ACID TEST Hycel, Inc. | KNK |
| Jul 27, 1978 | K780946 | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER Hycel, Inc. | JPJ |
| May 3, 1978 | K780464 | LELECTIVE KINETIC SYSTEM-60 Hycel, Inc. | JJE |
| Apr 5, 1978 | K780262 | DIRECT UREA NITROGEN TEST Hycel, Inc. | CDW |
| Jan 30, 1978 | K772426 | 17-HYDROXY TEST Hycel, Inc. | CDB |
| Aug 22, 1977 | K771259 | ALBUMIN TEST, HMA ALBUMIN TEST Hycel, Inc. | CIX |
| Aug 10, 1977 | K771353 | PLATELET COUNTER & HEMATOCRIT ACCES. Hycel, Inc. | GKL |
| Aug 10, 1977 | K771343 | LDH-INT TEST Hycel, Inc. | CFH |
| Jul 21, 1977 | K771154 | CPK-INT TEST Hycel, Inc. | |
| Jul 11, 1977 | K771107 | COUNTER 700 & HC-700 HEMO 0 REF. Hycel, Inc. | GKL |
| Jul 5, 1977 | K770803 | HEMOTOLOGY PRODU&TS (5 IN ALL) Hycel, Inc. | GKK |
| Jun 24, 1977 | K770643 | CREATININE TEST, SUPER SEVENTEEN Hycel, Inc. | CGX |
| Jun 1, 1977 | K770748 | TEST, FERROZINE IRON & IRON BINDING Hycel, Inc. | JMO |
| Apr 26, 1977 | K770393 | PROPANE, HIGH PURITY, INSTRUMENT GRADE Hycel, Inc. | JJO |
| Nov 1, 1976 | K760468 | TEST, REFORMULATED HYCEL HMA CALCIUM Hycel, Inc. | CIC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||